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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011128
Receipt No. R000013034
Scientific Title Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension.
Date of disclosure of the study information 2013/08/01
Last modified on 2016/07/14

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Basic information
Public title Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension.
Acronym Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension.
Scientific Title Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension.
Scientific Title:Acronym Study of the pulmonary artery blood flow dynamics analysis by phase-resolved three dimensional cine phase-contrast magnetic resonance imaging in patients with pulmonary arterial hypertension.
Region
Japan

Condition
Condition Pulmonary arterial hypertension
Classification by specialty
Cardiology Radiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Although phase-resolved 3D phase-contrast MRI allows non-invasive measurement of hemodynamic parameters in patients with pulmonary arterial hypertension in vivo, enough knowledge is not provided. The aim of this study is 1) to measure the flow parameters including flow velocity and wall shear stress by using MRI in the pulmonary artery in patients with PAH. 2) to evaluate the clinical efficacy of these parameters.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hemodynamic parameters obtained by MRI (arterial flow velocity, wall shear stress)
The occurrence of clinical events
Hemodynamic parameters obtained by right-sided heart catheterization
Hemodynamic parameters obtained by ultrasonic cardiography
6-minute walk distance
Serum BNP level
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pulmonary arterial hypertension
Key exclusion criteria 1) Pulmonary hypertension due to left heart disease.
2) Paced rhythm
3) Pregnant or breast-feeding
4) Inability to obtain informed consent
5) Claustrophobia
6) Contraindication of contrast enhanced MRI
7)Inappropriate patients due to other reasons
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Hiroshi Watanabe
Organization Hamamatsu University School of Medicine
Division name Clinical Pharmacology & Therapeutics
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL 053-435-2385
Email hwat@hama-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Keiichi Odagiri
Organization Hamamatsu University School of Medicine
Division name Clinical Pharmacology & Therapeutics
Zip code
Address 1-20-1, Handayama, Higashi-ku, Hamamatsu
TEL 053-435-2385
Homepage URL
Email kodagiri@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.springerplus.com/content/5/1/1071
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2015 Year 12 Month 01 Day
Date analysis concluded

Other
Other related information 1. To evaluate the relationship between blood flow parameters of pulmonary artery and hemodynamic parameters obtained by right-sided heart catheterization and UCG
2. To evaluate the prognostic value of blood flow parameters

Management information
Registered date
2013 Year 07 Month 05 Day
Last modified on
2016 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013034

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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